ClinicalTrials.gg
Active, not recruitingNCT07470983Updated Oct 13, 2026

A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

A Phase 2 interventional study of HRS-1780 Tablets and Placebo in Primary Aldosteronism, sponsored by Shandong Suncadia Medicine Co., Ltd.. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.

02

Conditions studied

  • Primary Aldosteronism

Browse trials for

03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's enrollment of 61 is close to the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, aged ≥ 18 years on the date of signing the form.
  2. Diagnosed with primary aldosteronism.
  3. Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .
  4. Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.
  5. From the signing of the informed consent form until 4 weeks after the last dose, the participant has no plan for procreation and is willing to adopt the highly effective measures specified in the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Has known secondary causes of hypertension.
  2. Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.
  3. Estimated (eGFR) \< 30 mL/min/1.73 m².
  4. Has had any of an organ system within 5 years before screening.
  5. Has received any other drug within 90 days or 5 half-lives before screening (whichever is longer).
  6. Has a history of blood donation or blood loss ≥ 400 mL within 3 months before screening, or has received a blood transfusion within 2 months.
  7. Known or suspected alcohol or narcotic abuse.
  8. Women who are pregnant, breastfeeding, planning pregnancy, or of unable to adopt highly effective measures; or men unable to adopt highly effective contraceptive measures.
  9. Abnormal daily routine.
  10. Use of strong inhibitors/inducers of cytochrome P450 3A4 () within 1 week before randomization.
  11. Severe infection, severe trauma, or major or medium-scale surgery within 1 month prior to screening;
  12. Stroke, , myocardial infarction, symptomatic heart failure ( III-IV), or coronary revascularization within 3 months prior to screening; and/or planned coronary, carotid, or peripheral artery revascularization at the time of screening;
  13. Within 6 months prior to the screening period, participants have diseases that, in the judgment of the investigator, may interfere with the trial results or pose additional risks to the administration of the study drug, including but not limited to respiratory, digestive, cardiovascular, endocrine, immune, urinary, adrenal (except for the primary disease), hematological, neurological, psychiatric, or other conditions;
  14. Presence or suspected presence of depression, bipolar disorder, suicidal tendencies, schizophrenia, or other severe mental disorders; or participants with mental incapacity or language barriers that prevent them from adequately understanding or participating in the trial process;
  15. (ALT) ≥ 3 × (ULN);
  16. Aspartate aminotransferase (AST) ≥ 3 × ULN;
  17. In the judgment of the investigator, any condition that may affect participant safety or otherwise interfere with the evaluation of trial results (including medical, psychological, social, or geographical factors).
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    HRS-1780 Tablets

    Drug: HRS-1780 Tablets

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in office systolic blood pressure (SBP);

    Time frame: up to Week 8

Secondary outcomes

  1. Rate of achieving office blood pressure <140/90 mmHg;

    Time frame: up to Week 8

  2. Rate of achieving office blood pressure <130/80 mmHg;

    Time frame: up to Week 8

  3. Change from baseline in office diastolic blood pressure (DBP) ;

    Time frame: up to Week 8

  4. Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;

    Time frame: up to Week 8

  5. Change from baseline in 24-hour ABPM daytime and nighttime SBP and DBP ;

    Time frame: up to Week 8

  6. Change from baseline in serum potassium (K+) and serum sodium ;

    Time frame: Weeks 2, 4, and 8

  7. Total cumulative dose of potassium supplement (potassium chloride) ;

    Time frame: up to Week 8

  8. Proportion of participants with a ≥30% decline in estimated glomerular filtration rate (eGFR);

    Time frame: up to Week 8

  9. Proportion of participants with 5.5 < K+ ≤ 6.0 mmol/L;

    Time frame: up to Week 8

  10. Proportion of participants with K+ > 6.0 mmol/L;

    Time frame: up to Week 8

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2026
First posted
Mar 13, 2026
StartActual
Apr 23, 2026
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 13, 2026
Enrollment
60 (estimated)→61 (actual)
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Recruiting→Active, not recruiting
    Enrollment 60 (estimated)→61 (actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07470983
Responsible party
Sponsor
First posted
Mar 13, 2026
Start date
Apr 23, 2026
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 13, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: HRS-1780

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